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Category: Industry


Cell and Gene Therapy, Industry

Pfizer setback brings questions for Duchenne gene therapy ahead of Sarepta decision

June 13, 2024

Via: Biopharma Dive

The failure of a Pfizer medicine for Duchenne muscular dystrophy adds new uncertainty around the effectiveness of gene therapy for the muscle-wasting condition, days before the Food and Drug Administration is expected to decide on expanding use of a similar […]


FDA, Industry, Regulations, Vaccines

FDA Gives Nod to RSV Vaccine for People in Their 50s

June 10, 2024

Via: Drugs.com

The U.S. Food and Drug Administration on Friday has for the first time approved the use of a respiratory syncytial virus (RSV) vaccine for people in their 50s who are at increased risk for the illness. Drugmaker GSK’s Arexvy vaccine, […]


FDA, Industry, Regulations, Vaccines

FDA advisers back updating COVID shots to target JN.1 virus family

June 6, 2024

Via: Biopharma Dive

A group of advisers to the Food and Drug Administration on Wednesday unanimously recommended that COVID-19 vaccines be updated to cover coronavirus strains with a family known as JN.1 ahead of the fall. The committee, which had originally been scheduled […]


Cell and Gene Therapy, Industry

Gene Therapy in Both Ears Restores Hearing to Babies Born Deaf

June 5, 2024

Via: Drugs.com

Chlidren born deaf have had their hearing restored in both ears as a result of gene therapy, a new study reports. All five children showed hearing recovery in both ears, with dramatic improvements in speech perception and the ability to […]


Industry, Vaccines

U.S. Will Make Millions of Bird Flu Vaccines This Summer

June 3, 2024

Via: Drugs.com

As the H5N1 avian flu continues to spread among dairy cows in the United States, nearly 5 million doses of flu vaccine are now being prepared for possible use in humans. Since the outbreak in livestock began this spring, bird […]


FDA, Industry, Regulations, Vaccines

Moderna wins FDA approval for RSV vaccine

May 31, 2024

Via: Biopharma Dive

The Food and Drug Administration on Friday approved a third vaccine for respiratory syncytial virus, clearing a shot from biotechnology company Moderna one year after granting a green light to vaccines from GSK and Pfizer. The vaccine, dubbed mResvia, is […]


Industry, Vaccines

Vaccines Will Be Best Defense Against Bird Flu, Experts Say

May 29, 2024

Via: Drugs.com

Humanity’s best protection against bird flu will be the development of effective vaccines, a new study says. The H5N1 avian flu has been raging through cattle and poultry in the United States, increasing fears that the virus will make the […]


Cell and Gene Therapy, Industry

Merck KGaA to buy gene therapy tools maker for $600M

May 23, 2024

Via: Biopharma Dive

Merck KGaA’s dual roles as a CDMO and traditional pharmaceutical research company make it increasingly rare in the industry. The company also has an electronics unit with expertise in semiconductors, displays and surface materials. The purchase of Mirus helps to shore up […]


Industry, Vaccines

Repeat COVID Vaccination Could Shield Against Wide Range of Viruses

May 21, 2024

Via: Drugs.com

Powerful COVID vaccines could be setting people’s immune systems up to successfully fight off not just future COVID variants, but other types of coronaviruses as well, a new study shows. People repeatedly vaccinated for COVID — the initial shots, followed […]


Cell and Gene Therapy, Industry, Manufacturing, Research and Development

Addressing Performance, Scalability, and Regulatory Challenges to Accelerate Cell Therapy Manufacturing

May 16, 2024

Via: Biopharm International

To date, the FDA has approved 36 cell and gene therapy products. In the past decade, new cell therapy modalities such as chimeric antigen receptor T-cell (CAR-T) immunotherapies have emerged as promising treatments especially for many types of cancers. There […]


Biotech, Industry

Blackstone-backed biotech launches with up to $300M for immune drug

May 15, 2024

Via: Biopharma Dive

TSLP has become a popular target for drugmakers looking for new ways to tackle inflammation. Amgen and AstraZeneca entered the market first, after winning Food and Drug Administration approval in late 2021 for the asthma treatment Tezspire, an injection designed […]


Biotech, Industry

Sands Capital raises $555M fund amid upturn in biotech ‘crossover’ investing

May 14, 2024

Via: Biopharma Dive

Sands Capital has closed its latest life sciences investment fund, a $555 million haul that could help support biotechnology companies preparing to go public. The fund announced Tuesday, named Sands Capital Life Sciences Pulse Fund III, is the firm’s third […]


FDA, Industry, Regulations, Vaccines

FDA delays decision on Moderna’s RSV vaccine

May 13, 2024

Via: Pharmaphorum

The company said the FDA would not be able to complete its review of the mRNA-1345 vaccine by the scheduled date of 12th May due to “administrative constraints”, causing nervousness among investors that led to a near-3% decline in its […]


Industry, Mergers and Acquisitions, Vaccines

Novavax gets a lifeline with Sanofi vaccine pact

May 10, 2024

Via: Biopharma Dive

Allying with Sanofi is a boost for Novavax, which has seen its share price crumble and come under activist investor pressure as it struggles to sell its COVID shot. The company pitched the vaccine as an alternative to the dominant […]


Cell and Gene Therapy, Industry

Regeneron gene therapy improves hearing in two children

May 8, 2024

Via: Biopharma Dive

Regeneron’s announcement follows news that Eli Lilly’s competing experimental gene therapy gave an 11-year-old boy who was born deaf the ability to hear. The treatment, which Lilly acquired in a buyout of biotechnology company Akouos, also targets otoferlin. The results […]


Cell and Gene Therapy, Industry

Gene Therapy Improves Vision in People With Inherited Blindness

May 6, 2024

Via: Drugs.com

An injectable gene therapy caused measurable improvements in vision among a small group of people with inherited blindness, an early-stage clinical trial says. Researchers recruited 14 people with Leber Congenital Amaurosis (LCA), a rare genetic condition that causes babies to […]


Biotech, Industry

Delphia starts up with $67M to make a new type of cancer drug

May 2, 2024

Via: Biopharma Dive

Cancer research is always evolving, as scientists search for ways to combat the tricks tumors use to evade drug therapies. In the last decade alone, immunotherapies, targeted therapies, antibody-drug conjugates and radiopharmaceuticals have become standard treatment for a variety of […]


Cell and Gene Therapy, Industry

Astellas adds to ‘off-the-shelf’ cell therapy capabilities with Poseida deal

May 1, 2024

Via: Biopharma Dive

Astellas Pharma is betting again on cell therapy, announcing Wednesday a deal with Poseida Therapeutics to develop donor-derived treatments for cancer. Through the partnership, the companies aim to create two allogeneic, or “off-the-shelf,” cell therapies for solid tumors. Astellas will […]


Industry, Vaccines

Painless Skin Patch Could Deliver Vaccines to Kids

April 30, 2024

Via: Drugs.com

Kids who don’t like vaccination shots might soon have an alternative in a painless skin patch, researchers say. More than 90% of 190 Gambian infants were protected from measles and all were protected from rubella after receiving a single vaccine […]


Industry, Vaccines

Vaccines Have Saved 154 Million Lives, Mostly Babies, Over Past 50 Years

April 29, 2024

Via: Drugs.com

Global vaccination efforts have saved an estimated 154 million lives, including 101 million infants, a new study led by the World Health Organization (WHO) shows. Immunization has contributed more to the health and survival of newborns than any other medical […]